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The Biosecurity Law of the People’s Republic of China ("Biosecurity Law") has taken effect since April 15, 2021. It was reviewed for the first round by the Standing Committee of the National People’s Congress (“NPC”) in October 2019, and finally passed by the third round review by the Standing Committee of NPC on October 17, 2020.
It, for the first time, defines the concept of “Biosecurity”. In general, the Biosecurity Law presents the following features: ● The Biosecurity now constitutes a significant part of national security. It gives quite broad definition of “Biosecurity”, correspondingly addressing on a number of relevant areas.
● The Biosecurity Law requires to establish various systems and mechanisms. It is foreseeable that more regulations will be promulgated for their implementation. 1. Broad Definition of “Biosecurity” and Wide-Range Regulated Areas “Biosecurity” refers to the capacity that the state can effectively respond to the dangerous biological elements and relevant factors threats, maintain stable and healthy development in the biological field, keep the interest in a relatively safe and threat-free status, and ensure sustainable development and continued safety.
Therefore, any activities or matters related to dangerous biological elements (animals, plants, microorganisms, biotoxins and other bioactive substances) or relevant factors threats could be regulated by the Biosecurity Law. And the ultimate purpose is to identify, prevent, and effectively respond to such elements to ensure the stability of biotechnology, life and health of the people, ecological environment.
Specifically, the Biosecurity Law addresses the following areas: (1) preventing and controlling a major new or sudden outbreak of an infectious disease or an epidemic in animals or plants(防控重大新发突发传染病、动植物疫情); (2) research, development, and application of biotechnology; (3) Biosecurity administration of pathogenic microbe labs; (4) Biosecurity administration of human genetic resources (“HGR”) and biological resources; (5) preventing the invasion of alien species and protecting biodiversity; (6) dealing with microbial drug resistance; and (7) prevention of bioterrorism and defending threats of biological weapons. The catch-all clause “other activities related to Biosecurity” means the above areas are not exhaustive, especially considering the broad definition and fast development of Biosecurity. 2. Coordination Mechanism for National Biosecurity and Biosecurity Risk Prevention and Control Systems Considering the complexity and diversity of Biosecurity matters, there will be a Coordination Mechanism for National Biosecurity (“CMNB”) that consists of the competent departments of the State Council for health, agriculture and rural affairs, science and technology, and foreign affairs, as well as relevant military agencies, being responsible for analyzing national Biosecurity issues, and organizing, coordinating, and driving national Biosecurity work. And there will also be Provincial Coordination Mechanism for Biosecurity for implementing Biosecurity tasks in respective administration divisions.
The Biosecurity Law vows to establish various systems to prevent and control potential Biosecurity risks:(1) Biosecurity risk monitoring and early warning system; (2) Biosecurity risk investigation and assessment system; (3) Biosecurity information sharing system; (4) Biosecurity information release system; (5) Biosecurity directory and list system (a directory or list of materials, equipment, technologies, activities, important biological resources and data, infectious diseases, animal or plant epidemic diseases, invasive alien species involving Biosecurity, etc. subject to adjustments); (6) Biosecurity standards system; (7) Biosecurity review system; (8) Biosecurity emergency response system; (9) Biosecurity incident investigation and traceability system; (10) national access system for animals and plants, their products and high-risk biological factors that enter China for the first time or whose entry is resumed after suspension; (11) response system for significant overseas Biosecurity incidents. The Biosecurity Law gives only simple description about the abovementioned systems. Detailed regulations for their implementation and enforcement remain to be seen in the future. We think the above systems is demonstrating that:(1) China is strengthening administration over Biosecurity. Relevant government authorities are empowered to administer the Biosecurity matters, for example, conducting the Biosecurity assessment, inspecting organizations or premises for Biosecurity supervision;
(2) for the purpose of monitoring, prevention, or information sharing and issuance, to the extent permissible by the appliable laws, Biosecurity will prevail over those rights to data, personal information, privacy, confidential information of enterprises in certain circumstances. 3. Biotechnology Research, Development and Application Any biotechnology research, development or application is subject to ethical principles. Such activities will be classified into high-risk, medium-risk, and low-risk, based on their degree of impact on the public health, industry, agriculture, and the ecological environment.
For anyone who wishes to conduct high-risk and medium-risk activities: it must (1) be a legal person (i.e., an entity) established in China; (2) obtain relevant approval or filing; (3) conduct a risk assessment and propose risk prevention and emergency control plans for such activities.
An entity should also (1) take prevention and control measures, formulate systems for training, inspection and regular reporting; (2) make registration and filing for acquiring or importing regulated important equipment and special biological elements.
Moreover, any clinical research for new biomedical technologies is subject to ethical review. Such research shall be conducted by qualified medical institutions. 4. Pathogenic Microbe Labs China already regulates those laboratories in general, as well as ones that handle potentially dangerous pathogens through the regulations promulgated by the State Council and the chief healthcare regulator, the National Health Commission. The current regulations on pathogenic microbe laboratories require a person in charge to be primarily responsible for the Biosecurity of the laboratory.
The Biosecurity Law tightens the administration of pathogenic microbe labs. It additionally requires that the legal representative of the entity (i.e., the chief corporate responsible person) responsible for establishing the pathogenic microbe laboratory, together with the person in charge, to be liable for regulatory compliance. 5. HGR and Biological Resource For the first time, the Biosecurity Law provides that the Chinese state has sovereignty over all HGR and biological resources in China. HGR includes HGR Materials and HGR Information. However, the Biosecurity Law does not give a clear definition of biological resources.
For HGR, the Biosecurity Law is in line with the Administrative Regulations on Human Genetic Resources of the People’s Republic of China (“HGR Regulations”) in material aspects. The ethics approvals, prior notice and written consent are necessary for sampling, biobanking, utilizing HGR and external provision of HGR. In addition, approval from the Ministry of Science and Technology (“MOST”) is a must for the following activities in China:(1) to sample “certain category” HGR (certain category HGR refers to HGR of important genetic families or in specific areas in China, or collection of HGR of which the types and quantities are prescribed by MOST); (2) to biobank HGR; (3) international cooperation on scientific research by utilizing HGR between Chinese parties and foreign parties (foreign entity, individual or entity under their actual control); (4) provisions of HGR to foreign parties. There are also exceptions to the approval for other activities concerning HGR:
(1) a record filing procedure for clinical trials utilizing HGR: The Chinese parties and foreign parties shall make a record filing with MOST, specifying the categories, quantities and purpose for use before initiating the clinical trials if:
(2) a prior report to MOST for provision of HGR Information to foreign parties: under the HGR Regulation, transferring HGR Information or making them available to foreign parties requires a record filing submitted to MOST, together with the copy thereof for backup, provided that such HGR Information makes no harm to the public health, State security and public interest of China. Otherwise, MOST will have to conduct a security assessment. The Biosecurity Law changes the record filing to a “prior report”. It is unknown that the filing and prior report are the same essentially or they are substantially different. A foreign party cannot sample, biobank, utilize or transfer HGR abroad by itself, but it can:(1) utilize HGR or biological resources in the international cooperation on scientific research jointly with a Chinese partner; (2) obtain HGR Materials after approval from MOST; (3) obtain HGR Information after prior report to MOST; (4) obtain or utilize biological resources in China after receiving required approval. Violation of the Biosecurity Law may lead to various penalties including orders to cease activities, confiscation of income and materials, monetary fines (against the entity or an individual), for example:
(1) A foreign party will receive a monetary fine ranging from RMB one million to RMB ten million, if it illegally samples, biobanks China’s HGR (both biospecimens and data) or illegally transmits China’s HGR abroad without approval.
(2) The Biosecurity Law increases the monetary fine from 5-10 times to 10-20 times the value of illegally derived income for the foreign party’s illegal collection, biobank or provision abroad of China’s HGR (both biospecimens and data) without approval if the illegally derived income is more than RMB one million. There are debarment sanctions against those individuals who violate the Biosecurity Law, i.e., legal representative, person in charge, person directly responsible, and other persons directly liable: the maximum debarment penalty is now 10 years debarment from biotechnology research, development, and application activities.
朱圣雄 律师助理 外商投资专业委员会 业务专长：外商投资、公司与商事 zhusx@mhplawyer.com 
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发表于 2021-5-7 17:00:00
